Charlotte Smith

Background

About Charlotte Smith

Senior quality assurance professional with proven experience achieving compliance to required policies including for example ISO, ICH and UK, EU and FDA regulatory standards. Experienced in leadership of diverse teams and a team player, motivating others to meet GxP requirements and business expectations. PhD qualified with experience working in Research and Development. Extensive Quality Assurance experience alongside strong communications skills, an ability to influence and target driven to deliver proactive compliance. Proven and effective leader in project, laboratory and quality settings. I am an enthusiastic, flexible and proactive individual working to high professional standards. Over two decades experience working in Exposure to working in the Novartis international community in multiple disciplines and for my technical expertise, achievements and contribution to the global community in Pharmaceutical Microbiology I was awarded the title of ‘Technical Master in Quality’ by Novartis. Experienced providing quality oversight for GMP activities, implementation of company and regulations, supporting applicable customers from multiple technical disciplines to achieve compliance requirements. Adept in production and engineering issue management and risk mitigation with an ability to support identification of the best pragmatic solution. Certified auditor with nearly two decades experience leading numerous self-inspections and support of third party audits in addition to ISO 9001 Quality Management System Auditor / Lead Auditor qualification. Audit Specialist leading site audit preparations. At both Reckitt and Novartis managed risk based self-inspection plan. Frequently provided support in successful Health Authority inspections (including FDA, MHRA, KMFDS, PMDA, Eurasian Economic Union) in addition to corporate audit and customer inspections.Currently working to support for Reckitt External Manufacturing Organisations (EMOs) providing product classifications including medical devices, cosmetics and medicinal products. Manage a portfolio of EMOs to ensure compliance of Reckitt products by working directly with the EMOs and acting as the Reckitt quality contact. Responsible for assessment of EMOs and service providers against approved Reckitt standards and / or regulatory standards (e.g. ISO13485, ISO22716 and EU GMP). Interface with cross functional teams to support EMO activities: Regulatory, R&D, Technical, Packaging, Planning, Activity Management, Purchasing, Legal, Safety and Medical teams where necessary.